Ultrasonic methods for diagnosis and treatment of stroke

ABSTRACT

A medical diagnostic method, system and related equipment particularly adapted to diagnose disorders of the blood circulation serving the head and neck, and especially the brain. A preferred use of the system is early, rapid, accurate, diagnosis of stroke, especially whether the stroke is due to blockage of a blood vessel or leakage from the blood vessel.

Notice: More than one reissue application has been filed for the reissueof U.S. Pat. No. 7,037,267. The reissue applications are parent reissueapplication Ser. No. 11/823,811 filed Jun. 27, 2007 to which priorityfor this application is claimed under 35 U.S.C. §120; this divisionalreissue application; and divisional reissue application Ser. No.13/204,984 filed Aug. 8, 2011.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of Provisional Application No.60/164,586 filed Nov. 10, 1999. Friday, Nov. 10, 2000, was a holiday inthe District of Columbia; see 35 USC §119(e)(3).

TECHNICAL FIELD

This invention involves medical diagnostic methods, systems, andapparatus, particularly those intended for diagnosis of disorders in theblood supply to the brain.

BACKGROUND

There are many highly accurate techniques for diagnosing disorders ofthe brain and nervous system. Unfortunately, many of them require largeand immovable equipment, extremely sophisticated computers, and highlytrained personnel to operate them. They are not suitable for firstresponders, paramedics and other field medical personnel. They also arenot suitable for the rapid use that medical emergencies require.Similarly, they often are not suitable for use in surgical suites whereworking room is at a premium, and the large electromagnetic fieldsgenerated by some types of equipment are not compatible with otherequipment, tools, and personnel typically present.

Glossary

This document uses a variety of terms from science, engineering, andmedicine. Those not specifically defined below have the meanings thatthey ordinarily have in those fields. The following is a list ofspecialized terms most commonly used in this document.

Acoustic window (sometimes, acoustic bone window) refers to a portion ofthe skull that is thin enough to pass ultrasonic waves.

Aneurysms are portions of blood vessels that bulge outward or breakopen.

Aural refers to the ear or the hearing (auditor) system.

Cerebral, from the medical term cerebellum, refers to the brain.

Cranium is the medical term for the skeleton of the head, also commonlyknown as the skull.

Clinicians are people trained in medicine, such as physicians, nurses,paramedics, medical technicians, and the like.

Coupling is causing two or more things to work together.

Diagnosis is the act of determining whether a stroke has occurred, andif so what type it is or is not. It includes the process of“differential” diagnosing, which is identifying one type of strokesimultaneously with ruling out the possibility of another type.

Doppler refers to a technique of analyzing waves, in which the change intime of the frequency of waves reflected from an object indicates thespeed at which the object is moving toward or from the observer. It isresponsible for the familiar effect that the pitch of a sound rises asthe object approaches the observer and lowers as the object goes awayfrom the observer.

Emboli are little particles carried by the bloodstream into smallerblood vessels, where they block blood flow to cells beyond. They can beblood clots, bubbles or solids such as plaque. Emboli is the plural ofembolus. Embolic refers to a stroke that is caused by an embolus oremboli. Emboli that lodge in place can cause additional thrombi (seebelow) to form at the same location.

Harmonic refers to a wave having a frequency value that is a multiple ofthe frequency of some basic wave, called the fundamental (and usuallythe wave that is directed to an object). Every complicated wave ismathematically equivalent to a collection of the fundamental wave andall the possible harmonic waves, in varying amounts and intensities.

Hemorrhagic, meaning bloody, refers to bleeding. A hemorrhagic stroke isone due to a leakage of the blood supply serving a portion of the brain.

Hertz, abbreviated Hz, is the unit of frequency of a wave, defined asone complete cycle per second.

Imaging is the use of information about an object to determine, by humaneye or by a computer, something about the location or condition of theobject. It does not require the creation of an actual display of theimage that can be seen by a human, because computers (and really smartpeople) are fully capable of interpreting the various aspects of animage, such as intensity, location, size, etc., as if they were actuallyviewing a traditional image. An image can be two- or three-dimensional.An image can be fixed in time (sometimes called a static image), like aphotograph, or it can be moving in time (sometimes called a dynamicimage), like a motion picture.

Ischemic (“without chemicals”) refers to a condition in which tissuedoes not receive adequate blood supply. An ischemic stroke is caused bya partial or total blockage of the blood supply serving a portion of thebrain.

Kilohertz, abbreviated kHz, is a unit of one thousand Hertz.

Microparticulates are very small particles, including microbubbles(“tiny bubbles”), emboli, plaque, and the like.

Nasal refers to the nose.

Neurological refers to the brain and nervous system (the spinal cord andall the nerves).

Nidus is a Latin word for the location of origin of a disease process,such as the point where a blood clot first forms even if the clottravels elsewhere before doing damage.

Ocular refers to the eye.

Opening, in the context of a location of a transducer adjacent theskull, includes a natural opening in the skull, a man-made opening inthe skull, or an acoustic window through the bones of the skull.

Orbit is the medical term for the eye socket and the bones of the skullthat form it.

Patent is a term used in this document to include not just a citedpatent itself, but also any other patent issuing from a patentapplication claiming priority from the cited patent, e.g., acontinuation patent, a continuation-in-part patent, a division(sometimes called a divisional) patent, a reissued patent, or anreexamined patent.

PCT is an acronym for the Patent Cooperation Treaty administered by theWIPO (see below).

Perfusion is a medical term for fluid flow over or through an organ,such as the flow of blood through the cerebral vasculature.

Plaque is the term for fatty deposits that build up on the inside ofarteries, sometimes breaking loose and flowing through the body.

Stroke is the term for sudden loss of normal blood flow in a portion ofthe brain.

Temporary ischemic attacks, or TIAs, are temporary blockages of bloodflow in the brain that do not last more than 24 hours. They usually donot last more than a few hours. They generally do not cause permanentdamage that is easily perceived by the sufferer or observable by others.

Thrombolytic refers to the process of dissolving a thrombus, or theability to do so.

Thrombi are a kind of early-stage blood clot. The singular of thrombi isthrombus.

Thrombotic refers to a stroke caused when an artery of the brain narrowsto a point at which blood begins to clot at the point of narrowing.

tPA (sometimes t-PA) is the abbreviation for tissue plasminogenactivator, a “clot busting” drug known to be effective against ischemicstrokes.

Transcranial Doppler, or TCD, is a technique for directing ultrasonicwaves through the bones of the skull and analyzing the echoes withDopper Doppler techniques.

Transducers are devices that transform one form of energy into another,such as transforming electrical power into ultrasonic waves or viceversa.

Transorbital refers to crossing through the eye socket.

Ultrasound refers to sound waves having frequencies above the range ofhuman hearing, about 20 kHz, depending on the listener's age andprevious experience with loud sounds.

Vasculature is the medical term for blood vessels. It includes thearteries that supply fresh blood to tissue, and the veins that carryspent blood away from tissue.

WIPO is an acronym for the World Intellectual Property Organization, anagency of the United Nations that administers an international systemfor patent applications under the PCT (see above).

DISCLOSURE OF THE INVENTION

The invention represents an entirely new approach to medical diagnosticsystems, particularly those used to diagnose stroke. Because of this newapproach, the invention can be described in a large number of“embodiments,” none more preferred than any other in terms of scope orimportance.

Some embodiments of the invention can be described as a method, i.e., a“recipe” or procedure to achieve a result. Others can be described as asystem (i.e., a fully operating machine), some as an assembly (ie., a“kit” or collection that is intended to put together in a particularmanner, and which may or may not have been put together yet), and yetothers as a combination (i.e., a group of parts or pieces that arecapable of operation together, even if some were parts already presentand others had to be supplied). Similarly, parts or portions of each ofthese embodiments can be described as subsystems, submethods,subassemblies, or subcombinations.

In all embodiments, the invention involves diagnosis of stroke in apatient. More specifically, the invention permits diagnosis of whether astroke has occurred, and if so, what type of stroke it is.

The two most common types of stroke are hemorrhagic and ischemic. Oneway to determine hemorrhagic stroke is to identify at least one regionof relatively diffuse blood flow within the patient's brain, i.e.,finding a region in which the blood flow is outside the arteries,spreading between the brain cells. One way to determine ischemic strokeis to identify at least one location of inadequate blood flow within thepatient's brain. In this sense, “inadequate” flow is any condition inwhich causes less blood to flow for any reason, such as when one or morearteries serving the brain have a partial or total, are narrowed orotherwise reduced in size. The blood vessel itself may change shape, orit may be blocked or narrowed.

Other embodiments of the invention use a more sophisticated approach andspecifically distinguish between hemorrhagic and ischemic strokes. Oneway to do this is to identify either type of stroke in any manner thatpositively rules out the other. One particular way to do this is to forma two-dimensional or there-dimensional image of the brain. Such images(either of which could be fixed in time like a snapshot or moving like amotion picture) can be analyzed by a computer or by a clinician todiagnose not just whether the patient has suffered a stroke, butspecifically which kind.

Some embodiments use optional additional techniques to enhance strokediagnosis. For example, Doppler techniques can be used to form an imageof the flow of microparticulates. Hemorrhagic stroke can be identified(and the difference between hemorrhagic and ischemic stroke can beidentified) based on the relative flow rates of the microparticulates.In another example, harmonic techniques are used to compare thediffusion (if any) of blood flow between two or more areas of the brain.As noted before, diffuse blood flow indicates that blood is spreadingbetween cells instead of passing normally through the arteries in thevicinity.

In all embodiments, ultrasonic signals are generated and directed intothe brain. The ultrasonic waves strike their target, namely the braintissue, the blood vessels, and the blood itself. Some of the ultrasonicenergy is reflected, forming a reflected signal, or echo, from thebrain. Different targets produce different echoes. The echoes arereceived and processed into information that indicates the identity ofthe target, that is, the condition of the patient's brain.

Information from at least one reflected ultrasonic signal is analyzed todiagnose the patient. This may be accomplished using any convenientmethod or equipment already known to those skilled in the art of medicalultrasonic diagnosis. In general, the signals are converted into digitaldata and analyzed by a computer. Either the computer program willdiagnose the presence and type of stroke, or it will present the data inany convenient manner so that a clinician may make the diagnosis. Forexample, the program may produce the two-dimensional orthree-dimensional images described earlier.

A single ultrasonic transmitter, or several such transmitters, may beused to generate the ultrasonic signals. A single ultrasonic receiver,or several such receivers, may be used to detect the ultrasonic echoes.It is typical, but not required, for an ultrasonic transmitter andreceiver to be combined into a single unit. Therefore, the remainder ofthis document uses the term transmitter/receiver with the understandingthat the term includes a transmitter only, a receiver only, or both atransmitter and a receiver together. In the case of a transducer andreceiver together, the term includes physical or functionalcombinations, or separate devices that operate together as if they werephysically or functionally combined.

There may be one or more transmitter/receiver. Each may performindependently of the other, such as the case where one serves as thebackup to the other. However, if independent transmitter/receiversdisagree as to the presence, location, or extent of a stroke, it isnecessary to ignore one of them (for whatever reason, such as additionaldata gathered from another source), or to employ some other techniquefor resolving the disagreement. For example, one could require that theyagree with each other, either completely or within some “confidencelevel” or other way of designating agreement, otherwise a stroke is notdetected.

In a more advanced design, the signals from multipletransmitter/receivers may be coordinated together to provide a morerobust diagnosis. For example, the image areas of twotransmitter/receivers can be arranged to overlap and form a larger imagearea than either could provide alone. (The overlapping coverage of twoautomotive headlights is a common analogy.) This may lead to a situationin which “disagreement” between transmitter/receivers is expected. Forexample, a first transmitter/receiver may detect a stroke in an areaoutside the view of a second transmitter/receiver. The second unitshould not also indicate a stroke (a so-called “false positive”) unlessit is detecting a separate location of damage to the brain. However, ifthe first transmitter/receiver detects a stroke within the common area,and the second transmitter/receiver does not indicate a stroke, someother way to resolve the conflict must be used, as indicated before.

Each transmitter/receiver can be placed in any number of locations onthe patient's head, including (a) natural openings in the skull, (b)man-made openings in the skull; and (c) known acoustic windows in theskull (some of which are also natural openings but some of which areregions where the skull is relatively thin but not open naturally).

In the case of a transmitter/receiver that is mounted adjacent a naturalopening in the patient's skull, the typical locations are the ocularopenings (i.e., the eye sockets or orbits), the nasal openings, and theaural openings. Man-made openings can be made in any convenient locationusing techniques known to neurosurgeons such as drilling a hole,removing a plate-shaped portion of skull, etc. It is optionally possibleto use equipment designed to attach to the skull and provide a supportfor instruments. For example, the fixed base and movable/lockableball-and-socket approach disclosed in International Publication NumberWO 98/51229 (International Patent Application Number PCT/US98/51229)could be modified to accommodate a transducer/receiver instead ofcatheters.

Known acoustic windows include those known to clinicians as the anteriortemporal window, the posterior temporal window, the middle temporalwindow, the transorbital window, the lateral frontal window, theparamedian frontal window, and the suboccipital foramen magnum window.

Ultrasonic systems produce or detect signals better if atransmitter/receiver is “acoustically coupled” in the vicinity of thenatural or man-made opening, thus reducing signal loss due to reflectionand dissipation when the ultrasonic waves strike (from either direction)the surface of the tissue immediately within the opening. Often it issufficient for the transmitter/receiver to fit tightly within theopening and physically contact the tissue surface (or the surface ofother tissue which itself is acoustically coupled to the tissue ofinterest).

The apparatus may improve the acoustic coupling if a tight fit is notpresent. This includes any way of moving or pushing thetransmitter/receiver into greater contact with the opening, or with thetissue itself, or both. For example, a vacuum subsystem could be used topull the transmitter/receiver toward the opening or the tissue. Or, amotor and linkage could be used to push the transducer/receiver towardthe opening or the tissue. Or, an electronic or software-basedcorrection could be made as part of the imaging process. Of course,combinations of any two or more of these examples (or other approaches)could be used.

In other embodiments, to improve the quality of the acoustic coupling(and maintain sterile conditions), an optional “acoustic couplingmaterial” may be located between the transmitter/receiver and either theopening, the tissue, or both. Several such materials are already known,such as mineral oil, glycerin, propylene glycol, water and water-basedgels. Acoustic coupling material may be used alone or together with anysuitable subsystem to improve acoustic coupling.

In an even more specific arrangement, the actual degree or quality ofthe acoustic coupling is determined, and the image of the brain ismodified to account for that determination. This could involve, forexample, basing the determination of the type of stroke, in part, on thedegree or quality of the acoustic coupling. In the specific case inwhich an acoustic coupling material is used, the degree or quality ofthe acoustic coupling could be taken to be the same as, or in somemanner related to, the amount of acoustic coupling material present.

There are several embodiments of the invention that differ only in themanner in which the acoustic coupling material is used. The acousticcoupling material can be inserted into or removed from the apparatus.For example, a hole or other opening may allow the material to beinserted into its proper location. The positioning of the material couldbe done manually, or automatically by dispensing the acoustic couplingmaterial into position between the ultrasonic transmitter/receiver andthe opening in the skull. Optionally, the acoustic coupling material maybe within (or otherwise supported by) a disposable piece that can beeither manually or automatically inserted into or removed from theapparatus. Other embodiments would also include those in which theacoustic coupling material is received into position between theultrasonic transmitter/receiver and the opening in the skull. Theapparatus could have some type of feature to ensure that the disposablepiece containing the acoustic coupling material fits into the apparatusonly in a certain position or orientation. In another example, theapparatus, the disposable piece, or both could have features to ensurethat the disposable piece containing the acoustic coupling material isused only once.

A variation on this theme involves preventing the proper operation ofthe invention unless a sufficient degree or quality of acoustic couplingis present. For example, either the invention is “locked out” because itdetects that acoustic coupling is not present, or the apparatus islocked out unless some minimum sufficient amount of coupling is present.(Again, these conditions of acoustic coupling could be correlated withthe actual quantity of acoustic coupling material, if such material isused.) One way of locking out the apparatus is to prevent imaging in theabsence of sufficient acoustic coupling. Another way of accomplishingthe same result is for the apparatus to enable imaging only in thepresence of sufficient acoustic coupling. Any form of mechanical,electrical chemical, software-based, or other lockout technique issuitable.

A higher level of complexity is “closed loop” control of the degree orquality of the acoustic coupling (which could be the control of theamount of acoustic coupling material) based on image quality. That is,if the apparatus detects a degree of acoustic coupling that is near theadequate amount, the apparatus adjusts itself to improve the acousticcoupling. This could, for example, mean automatically increasing theamount of vacuum, or increasing the amount of acoustic coupling materialby transferring the proper amount from some reservoir within (oradjacent to but under the control of) the apparatus.

In any embodiment, the transmitter/receiver should be held in itsacoustically coupled position while transmitting or receiving ultrasonicwaves. Because this is not always possible, the various embodiments ofthe invention use the technique of “dynamic coupling” to maintain orimprove the ability of the invention to diagnose stroke in real time.

For example, dynamic coupling could be done by permitting thetransmitter/receiver to move, but automatically detecting the amount anddirection of such motion (in any convenient manner) and using suchinformation for either of two purposes (or for some combination of thetwo). In either purpose, the motion of the transmitter/receiver does notreduce the ability to diagnose stroke; in fact, it may improve thatability.

The first purpose is to simply move the transmitter/receiver back to itsoriginal location, a subprocess known as “stabilization” for purposes ofthis invention. This subprocess is passive in the sense that it assumesthat returning the transducer/receiver back to its former position isall that is needed under the circumstances.

The second purpose is to compensate for changes in the ultrasonic signal(either the transmitter signal or the echoed signal), if any, caused bythe motion. This second purpose may involve actually moving thetransducer/receiver, or it may involve modification of the imagingprocess, or some combination of the two. The second purpose isaccomplished in a subprocess known as “compensation” for purposes ofthis invention. This subprocess is active in the sense that the qualityof diagnosis determines the extent of motion of the transducer/receiver,or the type or amount of image modification, or both.

The vacuum system described above in the context of acoustic coupling isone preferred component of the dynamic coupling subsystem. In oneembodiment, a platform defining one or more suction ports is positionedadjacent the opening in the skull. The platform is held to the patientby applying suction to at least one suction port. The ultrasonictransmitter/receiver is supported by the platform. Thus, by dynamicallycontrolling the amount and location (in the case of multiple independentsuction ports) of the vacuum, the transmitter/receiver is dynamicallystabilized. Preferred configurations of this embodiment are suitable forcurved, oval or circular openings: the platform forms a curved, oval, orcircular arc so that the platform surrounds at least a portion of theopening. Even more preferred is a platform having at least two portions,each of which is shaped in at least a portion of the curve, oval, orcircle, and arranged on generally opposite sides of the opening. Evenmore portions are possible, and such multi-portion embodiments permitgreater control over the dynamic coupling technique.

Instead of a vacuum-based subsystem (or working together with it),actuators of any suitable type may be used to either improve theacoustic coupling, or to move the transmitter/receiver.

Another technique of dynamic coupling combines multiple diagnostictechniques for purposes of improving the overall value of the diagnosis.For example, any embodiment described above that employs ultrasonicimaging may be combined with any other technique for diagnosis ofstroke. Data from the non-ultrasound technique can then be used tomodify the image from the ultrasound transducer/receiver, or thediagnosis based on that image. Similarly, an overall diagnosis may bemade using any combination of individual results from each technique.Suitable non-ultrasonic diagnostic methods include, but are not limitedto: computed tomography (“CT”) scanning; magnetic resonance (“MR”)scanning; differential spectrophotometric methods, near-infrareddetection of tissue characteristics; detection or measurement of certainbiological materials or chemicals (e.g., the enzyme known as S100β),which could be done by any convenient method, including use of miniaturesilicon electronic biological assays (“lab-on-a-chip”) and techniques;detection of changes such as blood pressure, pressure within the eye,blood flow in the arteries serving organs other than the brain (such asthose serving the eye), etc. For convenience, the apparatus used in anon-ultrasonic diagnostic technique is also referred to as atransducer/receiver below, because functions analogous to those of anultrasonic transducer/receiver are also being performed.

In any embodiment, the invention may be adapted into a portable versionsuitable for use by first responders, paramedics and other field medicalpersonnel. This involves modifications such as portable power supplies(e.g., single use or rechargeable batteries); or equipping the inventionwith suitable telemedicine features such as wireless transmission ofdata, on-board or remote data storage, etc.; or equipping the inventionwith features such as self-check diagnostics, alphanumeric or graphicaldisplays of menus, commands, or other information, and the like.

Some versions of the invention are combinations of separate transducerunits that mount in vacuum coupler units and are connected to imageprocessor units. Others are unified or integrated combinations, such asa helmet-based unit in which the transducer, vacuum units, and imageprocessors are all mounted on the helmet.

In any embodiment, image processing may include the use of expertsystems, neural networks, or both.

In any embodiment, the invention may be adapted to for use in surgicalsuites. For example, the invention may be employed during or aftercardiac surgery to detect strokes that are known to occur ascomplications in a small number of such cases.

In any embodiment, the invention may be employed to additionally deliverultrasonic energy during the administration of therapy, such as tPA, inresponse to a diagnosis of stroke, so that the ultrasonic energy mayimprove the effectiveness of the therapy.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-5 are schematic diagrams of various embodiments of theinvention.

FIG. 6 is a schematic cross sectional diagram taken along line 6-6 ofFIG. 5.

FIG. 7 is a schematic cross sectional diagram taken along line 7-7 ofFIG. 6.

FIGS. 8-10 are schematic diagrams of other various embodiments of theinvention.

FIG. 11 is a schematic cross sectional diagram taken along line 11-11 ofFIG. 10.

FIGS. 12-14 are schematic diagrams of variations on the embodiment ofFIG. 11.

The drawings are schematic representations only. They are not intendedto show all specific details discussed below, or those that might beincluded in a commercial version of any such embodiment. Features shownin one or more Figures could be combined, even if they are notillustrated together in a single FIGURE.

DETAILED DESCRIPTION

The following description is not intended to limit the technological orlegal scope of the invention. For example, examples of variousembodiments of the invention are only aids to understanding thefeatures, functions, and benefits of the invention in its broadestsense.

FIG. 1 is a schematic diagram of an embodiment of the invention in use,a situation generally indicated as 1. Boxes 2 and 3 illustrate portionsof this embodiment that optionally may be physically separated from eachother, but act cooperatively, using standard remote communicationstechniques, whether wired or wireless. The invention is used to diagnosestroke in a patient 4. Ultrasonic energy is generated in generator 5,then sent to and received from the patient 4 by transducer 6. The imager9 interprets the reflected signal, which is affected (in part) by thenature and quality of the dynamic coupling 8 of the transducer 6 to thepatient 4. The scope of the invention is not limited to the manner inwhich the nature and quality of dynamic coupling 8 is determined. Forexample, one of many potential techniques is the use of one or morecontact sensor(s), pressure sensors, position sensors, etc. (all notshown), according to known principles. Another very important way isanalysis of the quality and nature of the reflected ultrasonic signalitself, such as by comparison to baseline data or other parameters.

In any event, actuator 7 may improve the diagnosis in a closed feedbackand control loop. In this regard, it should be emphasized that FIG. 1 isschematic only and that the invention is not limited to a separateand/or mechanical actuator 7 operating directly on transducer 6,although that is one possible embodiment. The invention includeselectronic “actuation” in the sense of electronic and/or mathematicaladjustment to any or all of generator 5, transducer 6, imager 9, or (asdescribed below) dynamic coupling 8 itself.

In general, imager 9 performs any process for identifying data relevantto the diagnosis of stroke. This includes techniques for automaticallydetecting symptoms based on any relevant criteria. The imaging may bequalitative or quantitative in nature and/or the manner in which it isreported. For example, imager 9 may execute an algorithm for scanningthe brain to identify potentially likely symptoms of stroke, thenanalyze such regions in greater detail using one or more techniques. Indoing so, it may perform digital calculations related to the diagnosisof stroke and transmit relevant data to a remote location for fulldiagnosis and/or confirmation using telemedicine techniques. Yet, in thevicinity of the patient, the result of the calculation may be reportedin only a simpler “stroke/no stroke” manner, such as a display which iscolored red for adequate perfusion and blue for inadequate perfusion,however quantitative the basis for determining adequacy of perfusion maybe.

An optional, non-ultrasonic, detection of symptoms of stroke,illustrated schematically as 10, may also be used confirm, modify, orreject a diagnosis of stroke; as an input to the dyqamic coupling oftransducer 6 to the patient 4; or as input to the imaging process.

An optional wired or wireless communication link 11 may be used totransmit any form or content of data to another location, for anypurpose. This would include any manner of reporting the results of thediagnosis as described above, or any other relevant information aboutthe status of the system, the patient, etc.

FIG. 2 is a schematic representation of another embodiment of theinvention. Transducer 6 is dynamically coupled to the patient 4 betweentransducer 6 and the patient's skull 11 in the vicinity of an opening12. In the embodiment shown in the Figure, an optional by acousticmaterial 20 is used to improve the acoustic coupling of transducer 6 tothe patient. The relative sizes of the transducer 6, amount of acousticmaterial 20 (if used), and opening 12 are shown in schematic form only.

Within the patient's brain 19 are several portions of cerebralvasculature that are imaged by the invention to diagnose stroke in thepatient 4. Artery 13 is blocked by blockage 14 and thus the flow ofblood downstream is inadequate. This is an example of ischemic stroke.Artery 15 is partially blocked by partial blockage 16 and thus the flowof blood downstream is diffused by the partial blockage and may bedetected accordingly. (Typical whole or partial blockages are plaque,emboli, and the like.) By contrast, artery 17 is not blocked at all, butit has burst and thus diffuse blood flow 18 is present outside thevasculature and may be detected accordingly. This is an example ofhemorrhagic stroke. Of course, these descriptions are for ease ofillustration and should not be taken as limitations on the usual andwell-understood medical description of the various types of stroke andthe mechanisms that cause them. In any event, transducer 6 is used todiagnose any or all of these conditions in the patient in accordancewith the principles of the invention.

FIG. 3 is a schematic illustration of an alternative (or additional)dynamic coupling technique. Vacuum source 21 is used to generate and (ifdesired) control the dynamic coupling of transducer 6 to the patient 4,by use of a vacuum in chamber 22.

FIG. 4 is a schematic illustration of an alternative (or additional)actuation technique. Transducer 6 is mounted so as to move in one, two,or (as illustrated) three directions according to the motion of ball 23in socket 24. There are many specific techniques and devices for suchactuation, and the invention is not limited to any of them, thus theyare not shown for clarity.

FIGS. 5-7 are schematic illustrations of an alternative (or additional)acoustic material application technique. Acoustic material is containedwithin a separate (reusable or disposable) cartridge 25 that has aremovable release liner (not shown for clarity) or an acousticallytransparent window or fabric 26 designed to contact patient 4. Cartridge25 connects to transducer 6 by some appropriate interlock technique. Forexample, FIG. 6 shows an interlock in which the angles α and β aredifferent from each other to ensure that the cartridge is orientedproperly. FIG. 7 shows the use of marks to indicate proper rotation ofcartridge 25 onto transducer 6. In any or all of these embodiments,cartridge 25 could be connected to an adapter or other intermediatefeature instead of directly to transducer 6.

FIG. 8 schematically illustrates an embodiment in which a system fordispensing acoustic coupling material across in a controlled manner isused. A source 27 of acoustic coupling material replenishes a chamber 28that couples the transducer 6 to the patient 4 through some type ofinterface 29 (for example, the acoustically transparent window or fabric26 of FIG. 7). As before, the source 27 can act in the role of theactuator 7 and thus be part of the closed loop control of the dynamiccoupling of transducer 6. Chamber 28 may be part of a removable ordisposable cartridge 25 as shown in FIGS. 5-7.

FIG. 9 schematically illustrates the combination of the invention aspreviously described into an otherwise conventional portable automaticexternal defibrillator (AED) 30. There are many advantages to thiscombination, including (without limitation) the ability to share acommon power supply (batteries, recharging circuits for rechargeablebatteries, etc.) and associated switches (e.g., a main power on-offcircuit controlled by a switch connected to a lid that opens andcloses); common data storage and removal (either by way oftelecommunications link 11, conventional removable data storage media,PC cards, etc.); common ambient condition and battery conditiontemperature sensors; coordinated detection of whether the defibrillatorelectrode gel and the ultrasonic transducer acoustic coupling materialare still suitable for use, based on temperature, age, or other factors;common audio/visual techniques and equipment for prompting users tofollow proper procedures for “one-touch” or other proper use of theequipment, depending on the symptoms observed in the patient and/orinstructions received from remote medical personnel (e.g., pre-hospitalprocedures such as the Los Angeles Prehospital Stroke Screen); commonself-test and diagnostic routines (whether performed according to aschedule, periodically, at random times, as dictated by equipment usage,etc.); coordinated remote transmission of the status of such routinesover the telecommunications link 11, or a shared communications port;and so on. Even greater advantages lie in the use of theelectrocardiogram (ECG or EKG) data gathered by conventional AEDs asinput into the dynamic coupling and/or imaging components of the strokediagnosis. Such data may be used to confirm, modify, or reject adiagnosis, in a manner similar to that described for the non-ultrasonicdetection of symptoms of stroke described above. Of course, any of thefeatures just mentioned that do not specifically require presence of anAED could be implemented in a “stand-alone” embodiment of the invention.

FIGS. 10-14 schematically illustrate an embodiment of the inventionsuitable for the acoustic bone window represented by the eye sockets. Ineach of these Figures, transducer 6 is shown as a matter of convenienceas having a circular cross section, but this is not a limitation on thescope of the invention. The actual shape of transducer 6 would bedictated by normal considerations of anatomy, engineering design, andthe like.

FIG. 10 shows an annular transducer 6 arranged to surround the iris 31(and thus also the pupil 32) of eye 33. For clarity only, these Figuresdo not show the eyelids, which are transparent at ultrasonicfrequencies, but this embodiment would typically be used with theeyelids closed and transducer 6 in contact with them instead of directlywith eye 33. As indicated by the dashed arrows, transducer 6 wouldtransmit and receive ultrasonic energy through the eye to the brain ofthe patient; the annular design reduces the amount of acoustic energypassing through the lens 34 (shown in dashed lines) within the eye 33 soas to minimize adverse effects such as cataracts. Other reductions inenergy follow from designing transducer 6 to minimize the amount ofacoustic energy that spreads in so-called “side lobes” from the mainpath of travel indicated in FIG. 10.

FIGS. 12-14 schematically illustrate possible patterns for individualtransducing elements within annular transducer 6. FIG. 12 shows acollection of vertically striped individual elements denoted X₁ toX_(n). FIG. 13 shows a collection of radially arranged sections. FIG. 14shows a grid of sections denoted X_(m,n) that could be activatedindividually or in groups according to any desired pattern (such asrows, columns, spokes, etc.). In each of these embodiments, individualtransducing elements can be activated by ultrasonic generator 5according to a time-based “rotation” or other pattern that enables threedimensional imaging techniques to be used by imager 9. Such“mini-tomographic” data may be gathered from two locations (twoeyesockets) of the patent 4 and electronically combined by imager 9 toprovide greater detail and thus accuracy of the diagnosis of stroke thatwould otherwise be available.

Of course, the use of multiple locations in the manner just described isnot limited to only the transducer designs illustrated in FIGS. 10-14,but is an embodiment of the invention that can be practiced with anysuitable transducer 6. For example, multiple transducers known as“EchoEye” by EchoCath, Inc. may be used to assemble a composite image byusing the data generated by slight changes in the position, frequencyand/or phase of the transducer, according to the principles taught inU.S. Pat. No. 5,373,845 (Gardineer et al.).

While the above description is in terms of diagnosis of stroke, itshould be noted that any embodiment of the invention could be used in atwo-step regimen in which the patient is first diagnosed with stroke,and then additional ultrasonic energy is delivered (perhaps at differentfrequency, power level and the like) during administration of a therapysuch as tPA.

Some embodiments of the invention employ modified or unmodified aspectsof otherwise known ultrasonic diagnostic systems. Such systems includethose commercially available from, or under development by: Sonosite,Pie Medical, Esaote, the Bracco Group, Philips Medical Systems, ATL,Hewlett-Packard, Agilent Technologies, Toshiba, Toshiba Medical Systems,Toshiba America Medical Systems, General Electric, General ElectricMedical Systems, EchoCath, Acuson, Endosonics, Aloka, Hitachi SiemensMedical Systems, Inc., 3D Echotech, Ecton, SPECS USA, Daum, and MultigonIndustries.

Some embodiments of the invention employ modified or unmodified aspectsof otherwise known non-ultrasonic diagnostic systems. Such systemsinclude those commercially available from, or under development by:Non-Invasive Technology, Baylor College of Medicine; the Center forInnovative Minimally Invasive Therapy (CIMIT) of Massachusetts(including its member organizations such as Massachusetts GeneralHospital, Brigham and Women's Hospital, Draper Laboratory, andMassachusetts Institute of Technology); Harvard Medical School;

-   -   Such systems also include those disclosed in any of the        documents listed below as incorporated by reference into this        document.

Equipment

The invention may be implemented using standard or custom ultrasonictransducers, transmitters/receivers, image generation equipment, etc.,by adapting such devices as appropriate to accomplish the objectivesdescribed above.

Suitable stabilization devices can be made by modifying existing cardiactissue stabilizers, such as any of the inventions described and claimedin:

-   -   International Patent Application number PCT/NL94/00156        (International Publication Number WO 95/01757)    -   U.S. Pat. No. 5,865,730 (Fox et al.)    -   U.S. Pat. No. 5,984,864 (Fox et al.)    -   U.S. Pat. No. 5,894,843 (Benetti et al.)

Suitable vacuum-based stabilization devices can be made by modifyingexisting commercially available vacuum-based cardiac tissue stabilizers.Examples include the Medtronic Octopus®, Octopus2®, and Octopus®2+TissueStabilization Systems, or any similar product.

Suitable vacuum-based stabilization devices can be made by modifyingknown vacuum-based cardiac tissue stabilizers such as any of theinventions described or claimed in:

-   -   U.S. Pat. No. 5,836,311 (Borst et al.)    -   U.S. Pat. No. 5,927,284 (Borst et al.)    -   U.S. Pat. No. 6,015,378 (Borst et al.)    -   U.S. Pat. No. 5,727,569 (Benetti et al.)    -   U.S. Pat. No. 6,032,672 (Taylor)    -   U.S. Pat. No. 5,906,607 (Taylor et al.)    -   U.S. Pat. No. 5,782,746 (Wright)    -   U.S. Pat. No. 5,865,730 (Fox et al.)    -   U.S. Pat. No. 6,071,295 (Takahashi)    -   U.S. Pat. No. 6,007,523 (Mangosong)    -   U.S. Pat. No. 6,007,486 (Hunt et al.)    -   U.S. Pat. No. 5,891,017 (Swindle et al.)    -   U.S. Pat. No. 5,885,271 (Hamilton et al.)    -   U.S. Pat. No. 6,019,722 (Spence et al.)    -   International Patent Application Number PCT/US96/15091        (International Publication Number WO 97/10753)

Other suitable stabilization devices can be made by modifying existingvacuum-based eye tissue stabilizers such as

Suction rings employed in Lasik™ brand laser surgery

Devices disclosed in U.S. Pat. No. 5,171,245 (Sher)

Any known algorithms for detecting emboli or other aspects of blood flowcan be used, including those described in the documents in the Appendix,and also:

-   -   U.S. Pat. No. 4,109,642 Reid et al.)    -   U.S. Pat. No. 5,042,490 (Federov et al.)    -   U.S. Pat. No. 5,348,015 (Moehring et al.)    -   International Patent Application Number PCT/US99/26740        (International Publication Number WO 00/27288)

The systems and methods employed in any known ultrasonic system may beadapted for use in embodiments of the invention. Such systems includethose disclosed and claimed in the references in the Appendix, andespecially the following:

-   -   U.S. Pat. No. 5,123,415 (Daigle)    -   U.S. Pat. No. 5,295,485 (Shinomura et al.)    -   U.S. Pat. No. 5,360,005 (Wilk)    -   U.S. Pat. No. 5,369,624 (Fukukita et al.)    -   U.S. Pat. No. 5,590,658 (Chiang et al.)    -   U.S. Pat. No. 5,690,114 (Chiang et al.)    -   U.S. Pat. No. 5,839,442 (Chiang et al.)    -   U.S. Pat. No. 5,904,652 (Gilbert et al.)    -   U.S. Pat. No. 5,957,846 (Chiang et al.)    -   U.S. Pat. No. 5,964,709 (Chiang et al.)    -   U.S. Pat. No. 6,106,472 (Chiang et al.)    -   U.S. Pat. No. 6,111,816 (Chiang et al.)    -   U.S. Pat. No. 5,709,209 (Friemel, et al.)    -   U.S. Pat. No. 5,722,412 (Pflugrath et al.)    -   U.S. Pat. No. 5,782,769 (Hwang et al.)    -   U.S. Pat. No. 5,817,024 (Ogle et al.)    -   U.S. Pat. No. 5,893,363 (Little, et al.)    -   U.S. Pat. No. 5,976,088 (Urbano et al.)    -   U.S. Pat. No. 6,004,270 (Urbano et al.)    -   U.S. Pat. No. 6,056,691 (Urbano et al.)    -   U.S. Pat. No. 6,086,537 (Urbano et al.)    -   U.S. Pat. No. 6,135,961 (Pflugrath et al.)    -   U.S. Pat. No. 6,126,608 (Kemme et al.)    -   U.S. Pat. No. 6,102,863 (Pflugrath et al.)    -   U.S. Pat. No. 6,106,468 (Dowdell)

Improvements

Based on this disclosure, there are several improvements to theinvention that are clearly desirable and already understood by theinventors to be within the legal scope of the invention. In general,this includes any improvement, currently known or later discovered, inareas such as portable electronics, ultrasonic imaging systems, computergraphics, signal processing, stroke diagnosis and treatment, and thelike, that is suitable for use with the invention.

Such improvements specially include those that do not depend for theirfunction, operation, or success on the specific medical condition anddiagnostic techniques this invention relies upon. In other words,improvements to any similar device that is not the invention could andshould be applied to the invention, as appropriate.

Examples of improvements within the currently understood scope of theinvention include:

Reduction in cost, weight, and power consumption.

Reduction in the time required to form an image.

Improvements in imaging quality

Reduction in time required to form an image.

Changes in shape, size, and format of the image.

Changes in shape, size, and format of the equipment.

Improved ergonomic design, such as improvement in the fit to thepatient, ease of use by the operator, or any type of adaptation to aharsh or otherwise specialized operating environment.

Substitution of materials for any reason.

Improved reliability or quality.

Improved graphics, resolution, larger screen size.

Faster transfer and processing of data.

Remote transmission and/or processing of data.

Provided they lie within the scope of the claims below, or areconsidered equivalent under the law, the legal scope of the inventionincludes any improvements or changes of the types described above, evenif they are developed after the date of this document.

DOCUMENTS INCORPORATED BY REFERENCE

The full disclosure of each of the following documents is incorporatedinto this document.

All books, articles, documents, publications, U.S. Patents, U.S. PatentApplications, and International Patent Applications cited elsewhere inthis document.

The following medical textbooks:

-   Aaslid (ed.), Transcranial Doppler Sonography (1986), ISBN    3211819355-   Babikian et al (eds.), Transcranial Doppler Ultrasound (2^(nd)    edition 1999) ISBN 0750699698-   Barnett (ed.), Stroke (3^(rd) edition, 1998), ISBN 0443075514-   Bogdahn et al. (eds.), Echoenhancers and Transcranial Color Duplex    Sonography (1998), ISBN 0632048565-   Bogousslavsky (ed.), Stroke Syndromes (1995), ISBN 0521453976-   Ebrahim and Harwood, Stroke (2^(nd) edition, 1999), ISBN 0192628763-   Greenberg (ed.), Neuroimaging: A Companion to Adams and Victor's    Principles of Neurology (2^(nd) edition, 1999), ISBN 0071346155-   Hademos et al., The Physics of Cerebrovascular Diseases: Biophysical    Mechanisms of Development, Diagnosis and Therapy (1998), ISBN    1563965585-   Jensen and Jensen, Estimation of Blood Velocities Using Ultrasound:    A Signal Processing Approach (1996), ISBN 0521464846-   McGahan and Goldberg (eds.), Diagnostic Ultrasound (1998), ISBN    0397516142-   Meyer, Diagnosis and Management of Stroke and TIAs (1982), ISBN    0201041847′ Semple et al., An Atlas of Stroke (2nd edition 1999),    ISBN 1850700826.-   Millikan et al. (eds.), Stroke (1987), ISBN 0812110161-   Newell and Aaslid, Transcranial Doppler (1991), ISBN 0881678368-   Poeck, et al. (eds.), New Trends in Diagnosis and Management of    Stroke (1987), ISBN 0387183698-   Sandler et al., Correlative Imaging (1989), ISBN 0683075020-   Tegeler et al., Neurosonology (1995), ISBN 0815187920-   Tempkin, Ultrasound Scanning (2^(nd) edition, 1998), ISBN 0721668798-   Weinberger (ed.), Non-Invasive Imaging of Cerebrovascular    Disease (1988) ISBN 08451-45045-   Whisnant, Stroke (1993), ISBN 07506057X-   Wiebers et al., Handbook of Stroke (1997), ISBN 0316947601.

The following engineering and medical literature:

-   Alexandrov et al., “The Evolving Role of Transcranial Doppler in    Stoke Prevention and Treatment,” Journal of Stroke and    Cerebrovascular Diseases (March-April 1998)-   Alexandrov et al., “Yield of Transcranial Doppler in Acute Cerebral    Ischemia,” Stroke (August 1999)-   Alexandrov et al., “High Rate of Complete Recanalizatoin and    Dramatic Clinical Recovery During tPA Infusion When Continuously    Monitored With 2-MHz Transcranial Dopper Monitoring,” Stroke (March    2000)-   Baumgartner et al., “Contrast-Enhanced Transcranial Color-Coded    Duplex Sonography in Ischemic Cerebrovascular Disease,” Stroke    (December 1997)-   Boas et al., “Preliminary Investigation Into The Use Of Near    Infrared Spectroscopy For Diagnosing And Monitoring Stroke,”    Proceedings of the SPIE Conference on Battlefield Biomedical    Technologies (volume 3712, April 1999)-   Boespflug, “Transcranial Doppler: First Results Of Exploration In    The Circle Of Willis” [French, online abstract in English], Journal    des Maladies Vascularies (1989)-   Can et al., “Transcranial Doppler Ultrasound Criteria for    Hemodyrismically Significant Internal Carotid Artery Stenosis Based    on Residual Lumen Diameter Calculated From En Bloc Endarterectomy    Specimens,” Stroke (October 1997)-   Chen et al., “Biomechanics of Ocular Pneumoplethysmography,” Journal    of Biomechanical Engineering (August 1993)-   Cheung et al., “Differentiation Between Intracerebral Hemorrhage and    Ischemic Stroke by Transcranial Duplex Sonography: Response,” Stroke    (August 1999)-   Cullinane et al., “Evaluation of New Online Automated Embolic Signal    Detection Algorithm, Including Comparison With Panel of    International Experts,” Stroke (June 2000)-   Cunningham et al., “Miniature Silicon Electronic Biological Assay    Chip And Applications For Rapid Battlefield Diagnostics,”    Proceedings of the SPIE Conference on Battlefield Biomedical    Technologies (volume 3712, April 1999)-   Demchuk et al., “The Accuracy and Criteria for Localizing Arterial    Occlusion with Transcranial Doppler,” J. Neuroimaging (September    1999)-   Dietrich et al., “Thromboembolic Events Predispose the Brain to    Widespread Cerebral Infarction After Delayed Transient Global    Ischemia in Rats,” Stroke (April 1999)-   Furni et al., “‘Tail Sign’ Associated With Microembolic Signals,”    Stroke (April 1999)-   Kidwell et al., “Identifying Stroke in the Field: Prospective    Validation of the Los Angeles Prehospital Stroke Screen (LAPSS),”    Stroke (January 2000)-   Gee, “Ocular Pneumoplethysmography,” Survey of Ophthamology    (January-February 1985)-   Geissler, et al., “Cooling Gradients and Formation of Gaseous    Microemboli With Cardiopulmonary Bypass: An Echographic Study,”    Annals of Thoracic Surgery (July 1997)-   Giller et al., “Estimation of Vessel Flow and Diameter During    Cerebral Vasospasm Using Transcranial Dopper Indices,” Neurosurgery    (May 1998)-   Ginsberg et al. “Combating Hyperthermia in Acute Stroke,” Stroke    (February 1998)-   Ginsberg et al., “Noninvasive Diagnosis Of Extracranial    Cerebrovascular Disease: Oculoplethysmography-Phonoangiography And    Directional Doppler Ultrasonography,” Neurology (May 1979)-   Grocott et al., “Cerebral Emboli and Serum S100β During Cardiac    Operations,” Annals of Thoracic Surgery (June 1998)-   Gymnopoulos et al., “Low Pulsatility Signals Through the Orbits,”    Stroke (February 1996)-   Hoskins et al., “A Flow Model Of Cerebral Aneurysms For Use With    Power Doppler Studies,” British Journal of Radiology (January 1998)-   Hoskins, et al., “Colour Ultrasound Imaging Of Blood Flow And Tissue    Motion,” British Journal of Radiology (September 1997)-   Ito et al., “A Comparison Of The Accuracy Of Cerebral Blood Flow    Measurement Suing Transorbital Doppler Flow Velocity Vs.    Transcranial Doppler Flow Velocity,” Anesthesiology (September 1998,    Supplement)-   Kaposzta et al., “Clinical Application of Asymptomatic Embolic    Signal Detection in Acute Stroke: A Prospective Study” Stroke    (September 1999)-   Kemény et al., “Automatic Embolus Detection by a Neural Network,”    Stroke (April 1999)-   Klein et al., “Retinal Emboli and Stroke,” Archives of Ophthalmology    (August 1999)-   Klötzsch et al., “Emboli Detection During Continuous-Wave Doppler    Sonography of Internal Carotid Artery Stenosis,” Journal of Stroke    and Cerebrovascular Diseases (March-April 1998)-   Kogan et al., “Model-Based Visualization Of Ultrasound Images,”    Proceedings of the SPIE Conference on Battlefield Biomedical    Technologies (volume 3712, April 1999)-   Krongold et al., “Quadratic Time-Scale Detection Of Microemboli In    Flowing Blood With Doppler Ultrasound,” Proceedings of SPIE Signal    and Image Processing V (San Diego, Calif., 1997)-   Krongold et al., “Time-Scale Detection of Microemboli in Flowing    Blood with Doppler Ultrasound,” IEEE Transactions on Biomedical    Engineerin (September 1999)-   Larkin, “Sounding Out The Brain With Transcranial Doppler,” The    Lancet (Feb. 28, 1998)-   Leonhirth, “Near-IR Sensor Monitors Brain Lesions,” Biophotonics    International (July/August 1999)-   Levine et al., “‘Telestroke’: The Application of Telemedicine for    Stroke,” Stroke (February 1999)-   Ling, et al., “In Search Of Technological Solutions For Combat    Casualty Care,” Proceedings of the SPIE Conference on Battlefield    Biomedical Technologies (volume 3712, April 1999)-   Markus et al. “Microscopic Air Embolism During Cerebral Angiography    And Strategies For Its Avoidance,” The Lancet (Mar. 27, 1993)-   Markus et al., “Improved Automated Detection of Embolic Signals    Using a Novel Frequency Filtering Approach,” Stroke (August 1999)-   Martin et al., “Is The Continued Use Of Ocular Pneumoplethysmography    Necessary For The Diagnosis Of Cerebrovascular Disease?” Journal of    Vascular Surgery (February 1990)-   Mäurer et al., “Differentiation Between Intracerebral Hemorrhage and    Ischemic Stroke by Transcranial Color-Coded Duplex-Sonography,”    Stroke (December 1998)-   McRae et al., “Pressure And Volume Measurements From The Eye For    Detecting Possible Arterial Obstruction,” Annals of Biomedical    Engineering (January 1984)-   Miller et al. “Ultrasound Contrast Agents Nucleate Inertial    Cavitation In Vitro,” Ultrasound in Medicine and Biology (August    1995)-   National Institute of Neurological Disorders and Stroke, Proceedings    of the National Symposium on Rapid Identification and Treatment of    Acute Stroke, Dec. 12-13, 1996-   Nicholas et al., “The Cerebral Hyperperfusion Syndrome: Diagnostic    Value Of Ocular Pneumoplethysmography,” Journal of Vascular Surgery    (April 1993)-   Nuzzaci et al., “Duplex Scanning Exploration of the Opthalmic Artery    for the Detection of the Hemodynamically Significant ICA Stenosis,”    Stroke (April 1999)-   Petitti, “The Hyperdense Middle Cerebral Artery Sign,” Radiology    (September 1998)-   Polak et al. “Hypoechoic Plaque at US of the Carotid Artery: An    Independent Risk Factor for Incident Stroke in Adults Aged 65 or    Older,” Radiology (September 1998)-   Postert et al. “Contrast-Enhanced Transcranial Color-Coded    Sonography in Acute Hemispheric Brain Infarction,” Stroke (September    1999)-   Riechers et al., “Hemorrhage Detection Using Electromagnetic Waves:    Animal Test Results,” Proceedings of the SPIE Conference on    Battlefield Biomedical Technologies (volume 3712, April 1999)-   Rorick, “Indications for Diagnostic Tests in the Evaluation of    Stroke,” Heart Disease and Stroke (November/December 1994)-   Schmidt et al., “Noninvasive Prediction of Intracranial Pressure    Curves Using Transcranial Doppler Ultrasonography and Blood Pressure    Curves,” Stroke (December 1997)-   Schneider et al., “Noninvasive Assessment of Cerebral Collateral    Blood Supply Through the Ophthalmic Artery,” Stroke (January 1991)-   Shaffer et al., “Virtual Rounds: Simulation-Based Education In    Procedural Medicine,” Proceedings of the SPIE Conference on    Battlefield Biomedical Technologies (volume 3712, April 1999)-   Soller et al., “Noninvasive NIR Measurement Of Tissue Ph To Assess    Hemorrhagic Shock In Swine,” Proceedings of the SPIE Conference on    Battlefield Biomedical Technologies (volume 3712, April 1999)-   Spencer et al. “Transorbital Doppler Diagnosis Of Intracranial    Arterial Stenosis,” Stroke (September 1986)-   Steinke, “Power Doppler Imaging of Carotid Artery Stenosis,” Stroke    (October 1997)-   Stolz et at, “Frontal Bone Windows for Transcranial Color-Coded    Duplex Sonography,” Stroke (April 1999)-   Tong et al. “Incidence Of Transcranial Doppler-Detected Cerebral    Microemboli In Patients Referred For Echocardiography,” Stroke    (November 1994)-   Tong et al., “Transcranial Doppler-Detected Microemboli in Patients    With Acute Stroke,” Stroke (September 1995)-   Valdueza et at, “Monitoring of Venous Hemodynamics in Patients With    Cerebral Venous Thrombosis by Transcranial Doppler Ultrasound,”    Archives of Neurology (February 1999)-   Vuadens et al., “Diagnosis as a Guide to Stroke Therapy,” The Lancet    (1998 volume 352 Supplement III).-   Ward, “Seeing is Believing,” ADVANCE for Administrators in Radiology    and Radiation Oncology (January 1999)-   Warlow, “Epidemiology of Stroke” The Lancet, (1998 volume 352    Supplement III)-   Wolstenhuhne, et al., “The Agreement Between Colour Doppler Systems    In Measuring Internal Carotid Artery Peak Systolic Velocities,”    British Journal of Radiology (October 1997).

The following U.S. Pat. Nos. 6,135,961; 6,111,816; 6,106,472; 6,086,537;6,056,691; 6,004,270; 5,976,088; 5,975,081; 5,970,025; 5,967,991;5,967,991; 5,964,709; 5,961,462; 5,957,846; 5,954,675; 5,954,053;5,940,123; 5,938,607; 5,935,071; 5,924,988; 5,922,945; 5,921,928;5,919,138; 5,919,137; 5,917,190; 5,916,168; 5,904,652; 5,903,516;5,899,865; 5,897,851; 5,897,498; 5,893,363; 5,893,363; 5,891,035;5,879,303; 5,879,303; 5,873,821; 5,860,924; 5,855,556; 5,853,370;5,851,186; 5,839,442; 5,837,900; 5,833,613; 5,827,969; 5,820,558;5,817,024; 5,817,024; 5,807,263; 5,800,356; 5,795,297; 5,792,051;5,782,769; 5,782,769; 5,782,755; 5,779,631; 5,770,823; 5,770,801;5,769,079; 5,768,939; 5,762,067; 5,752,517; 5,729,508; 5,722,412;5,722,412; 5,720,710; 5,720,708; 5,720,291; 5,718,229; 5,715,823;5,713,362; 5,713,362; 5,707,607; 5,707,606; 5,690,114; 5,673,701;5,669,388; 5,669,388; 5,669,385; 5,664,574; 5,660,909; 5,655,539;5,648,942; 5,647,364; 5,645,066; 5,640,960; 5,636,631; 5,635,619;5,634,466; 5,634,465; 5,630,418; 5,617,863; 5,606,972; 5,603,323;5,596,987; 5,595,723; 5,590,658; 5,582,176; 5,573,751; 5,568,384;5,562,098; 5,558,855; 5,558,853; 5,558,094; 5,555,887; 5,553,614;5,546,946; 5,540,230; 5,540,230; 5,529,070; 5,517,994; 5,494,038;5,492,134; 5,492,121; 5,488,953; 5,485,842; 5,482,047; 5,482,045;5,479,930; 5,476,097; 5,474,073; 5,471,990; 5,471,989; 5,456,257;5,450,851; 5,438,994; 5,425,370; 5,425,370; 5,421,336; 5,409,688;5,409,005; 5,402,793; 5,402,778; ,390,675; 5,390,674; 5,386,827;5,381,795; 5,373,845; 5,373,845; 5,373,845; 5,365,929; 5,353,799;5,348,015; 5,343,865; 5,343,865; 5,343,865; 5,329,927; 5,329,927;5,329,927; 5,305,756; 5,295,485; 5,295,307; 5,287,753; 5,255,682;5,233,994; 5,226,422; 5,226,420; 5,215,094; 5,207,225; 5,197,477;5,187,672; 5,167,230; 5,161,536; 5,158,088; 5,123,415; 5,122,974;5,119,815; 5,103,827; 5,099,847; 5,095,910; 5,081,995; 5,076,278;5,076,278; 5,062,428; 5,050,610; 5,016,641; 4,975,892; 4,975,723;4,972,331; 4,926,871; 4,887,306; 4,883,059; 4,829,430; 4,817,618;4,800,317; 4,691,418; 4,670,339; 4,658,827; 4,657,895; 4,644,795;4,607,642; 4,603,702; 4,581,636; 4,567,895; 4,543,960; 4,542,653;4,508,122; 4,508,122; 4,431,006; 4,430,898; 4,417,582; 4,411,360;4,407,294; 4,399,704; 4,392,486; 4,354,502; 4,341,222; 4,298,009;4,298,009; 4,282,880; 4,282,755; 4,282,577; 4,277,979; 4,258,576;4,249,539; 4,237,902; 4,233,989; 4,222,274; 4,197,751; 4,197,749;4,168,628; 4,165,182; 4,153,894; 4,131,024; 4,035,822; 4,019,818;3,997,717; 3,978,508; 3,969,578; 3,953,822.

Alternative Embodiments

The following numbered aspects of the invention are part of the originaldisclosure of this invention. They are written as if they wereindividual inventions, so that they may be specifically considered assuch in subsequent applications. Thus, some of the following mayduplicate the claims at the end of this application. Some of them maycontain additional limitations than those claims.

-   1. Diagnosing stroke using dynamic coupling of at least one    ultrasonic transducer/receiver to a skull.-   2. Using non-ultrasonic detection of symptoms of stroke to    dynamically couple an ultrasonic transducer/receiver to a skull.-   3. The method of invention 2 in which the non-ultrasonic detection    comprises computed tomography scanning.-   4. The method of invention 2 in which the non-ultrasonic detection    comprises magnetic resonance scanning.-   5. The method of invention 2 in which the non-ultrasonic detection    comprises differential spectrophotometric methods or near-infrared    detection of tissue characteristics.-   6. The method of invention 2 in which the non-ultrasonic detection    comprises detection or measurement of a biological material.-   7. The method of invention 2 in which the non-ultrasonic detection    comprises detection or measurement of a chemical.-   8. The method of invention 2 in which the non-ultrasonic detection    comprises detection or measurement of A100β.-   9. The method of invention 2 in which the non-ultrasonic detection    comprises use of biological assay techniques.-   10. The method of invention 2 in which the non-ultrasonic detection    comprises detection of change in blood pressure.-   11. The method of invention 2 in which the non-ultrasonic detection    comprises detection of change in pressure within the eye.-   12. The method of invention 2 in which the non-ultrasonic detection    comprises detection of change in blood flow in arteries serving    organs other than the brain.-   13. The method of invention 2 in which the non-ultrasonic detection    comprises detection of change in blood flow in the arteries serving    the eye.-   14. For a patient having a skull containing brain tissue and blood    vessels, and in a process for diagnosing stroke in the patient, a    subprocess of dynamic coupling at least one ultrasonic    transducer/receiver to at least one opening in the skull.-   15. For a patient having a skull containing brain tissue and blood    vessels, and in a process for diagnosing stroke in the patient, a    subprocess of stabilizing at least one ultrasonic    transducer/receiver to at least one opening in the skull.-   16. For a patient having a skull containing brain tissue and blood    vessels, and in a process for diagnosing stroke in the patient, a    subprocess of compensating at least one ultrasonic    transducer/receiver coupled to at least one opening in the skull.-   17. For a patient having a skull containing brain tissue and blood    vessels, and in a process for diagnosing stroke in the patient, a    subprocess of compensating an image produced from at least one    ultrasonic transducer/receiver coupled to at least one opening in    the skull.-   18. For a patient having a skull containing brain tissue and blood    vessels, and in a process for diagnosing stroke in the patient, a    subprocess comprising:    -   a) dynamically coupling at least one of the ultrasonic        transmitter/receivers to at least one opening in the skull of        the patient; and    -   b) imaging the brain tissue or blood vessels.-   19. The subprocess of any of inventions 14 to 18, further comprising    generating and receiving ultrasonic signals suitable for processing    into information about the brain tissue or blood vessels.-   20. The subprocess of any of inventions 14 to 18, further comprising    applying a vacuum to the skull.-   21. The subprocess of any of inventions 14 to 18, further comprising    applying an acoustic coupling material to the skull.-   22. The subprocess of any of inventions 14 to 18, in which the    ultrasonic transducer/receiver is coupled to at least one man-made    opening in the skull.-   23. The subprocess of any of inventions 14 to 18, in which the    ultrasonic transducer/receiver is coupled to at least ocular opening    in the skull.-   24. The subprocess of any of inventions 14 to 18, in which the    ultrasonic transducer/receiver is coupled to at least one nasal    opening in the skull.-   25. The subprocess of any of inventions 14 to 18, in which the    ultrasonic transducer/receiver is coupled to at least one aural    opening in the skull.-   26. The subprocess of any of inventions 14 to 18, in which the    ultrasonic transducer/receiver is coupled to at least one acoustic    bone window in the skull.-   27. For a patient having a skull containing brain tissue and blood    vessels, a process for diagnosing hemorrhagic stroke in the patient,    comprising:    -   a) dynamically coupling at least one ultrasonic        transmitter/receiver to at least one opening in the skull of the        patient;    -   b) imaging a region within the skull of the patient; and    -   c) determining presence of hemorrhagic stroke by identifying        relatively diffuse blood flow within the skull of the patient.-   28. The process of invention 27, in which the imaging comprises    generating and receiving ultrasonic signals suitable for processing    into information about the region within the skull of the patient.-   29. The process of invention 27, in which a region is classified in    terms of normal blood flow.-   30. The process of invention 27, in which a region is classified in    terms of inadequate blood flow.-   31. The process of invention 27, in which a region is classified in    terms of relatively diffuse blood flow.-   32. The process of invention 27, in which locations of hemorrhagic    stroke are determined by identifying relatively diffuse blood flow    outside the blood vessels of the brain.-   33. For a patient having a skull containing blood vessels, a process    for diagnosing ischemic stroke in the patient, comprising:    -   a) dynamically coupling at least one ultrasonic        transmitter/receiver to at least one opening in the skull of the        patient;    -   b) imaging a region within the skull of the patient; and    -   c) determining presence of ischemic stroke by identifying at        least one location of inadequate blood flow within the skull of        the patient.-   34. The process of invention 33 in which the imaging comprises    generating and receiving ultrasonic signals suitable for processing    into information about the region within the skull of the patient.-   35. The process of invention 33 in which a region is classified in    terms of normal blood flow.-   36. The process of invention 33 in which a region is classified in    terms of inadequate blood flow.-   37. The process of invention 33 in which a region is classified in    terms of relatively diffuse blood flow.-   38. The process of invention 33 in which locations of ischemic    stroke are determined by identifying relatively inadequate blood    flow within the blood vessels of the brain.-   39. The process of invention 33 in which presence of ischemic stroke    is determined by identifying at least one location where there is at    least partial blockage of blood flow.-   40. For a patient having a skull containing brain tissue and blood    vessels, a process for diagnosing between hemorrhagic and ischemic    stroke, comprising:    -   a) dynamically coupling at least one ultrasonic        transmitter/receiver to at least one opening in the skull of the        patient;    -   b) imaging a region within the skull of the patient; and    -   c) classifying a region within the skull of the patient in terms        of adequacy of blood flow.-   41. The process of invention 40 in which the imaging comprises    generating and receiving ultrasonic signals suitable for processing    into information about the region within the skull of the patient.-   42. The process of invention 40 in which a region is classified in    terms of normal blood flow.-   43. The process of invention 40 in which a region is classified in    terms of inadequate blood flow.-   44. The process of invention 40 in which a region is classified in    terms of relatively diffuse blood flow.-   45. The process of invention 40 in which locations of hemorrhagic    stroke are determined by identifying relatively diffuse blood flow    outside the blood vessels of the brain.-   46. The process of invention 40 in which locations of ischemic    stroke are determined by identifying relatively inadequate blood    flow within the blood vessels of the brain.-   47. The process of invention 40 in which presence of ischemic stroke    is determined by identifying at least one location where there is at    least partial blockage of blood flow.-   48. The process of any of inventions 27, 33, or 40, further    comprising applying a vacuum to the skull.-   49. The process of any of inventions 27, 33, or 40, further    comprising applying an acoustic coupling material to the skull.-   50. The process of any of inventions 27, 33, or 40, in which the    ultrasonic transducer/receiver is coupled to at least one man-made    opening in the skull.-   51. The process of any of inventions 27, 33, or 40, in which the    ultrasonic transducer/receiver is coupled to at least ocular opening    in the skull.-   52. The process of any of inventions 27, 33, or 40, in which the    ultrasonic transducer/receiver is coupled to at least one nasal    opening in the skull.-   53. The process of any of inventions 27, 33, or 40, in which the    ultrasonic transducer/receiver is coupled to at least one aural    opening in the skull.-   54. The process of any of inventions 27, 33, or 40, in which the    ultrasonic transducer/receiver is coupled to at least one acoustic    bone window in the skull.-   55. For a patient having a skull containing blood vessels serving a    brain, a system for diagnosing hemorrhagic stroke in the patient,    comprising:    -   a) at least one ultrasonic transmitter/receiver receiver which        generates and receives ultrasonic signals suitable for imaging        the blood vessels of the brain,    -   b) at least one apparatus to dynamically couple any of the        ultrasonic transmitter/receivers to at least one opening in the        skull of the patient; and    -   c) a processor for imaging the blood vessels of the brain from        at least one signal received from at least one ultrasonic        transmitter/receiver.-   56. For a patient having a skull containing blood vessels serving a    brain, a system for diagnosing ischemic stroke in the patient,    comprising.    -   a) at least one ultrasonic transmitter/receiver receiver which        generates and receives ultrasonic signals suitable for imaging        the blood vessels of the brain,    -   b) at least one apparatus to dynamically couple any of the        ultrasonic transmitter/receivers to at least one opening in the        skull of the patient; and    -   c) a processor for imaging the blood vessels of the brain from        at least one signal received from at least one ultrasonic        transmitter/receiver.-   57. For a patient having a skull containing blood vessels serving a    brain, a system for discriminating between hemorrhagic stroke and    ischemic stroke in the patient, comprising:    -   a) at least one ultrasonic transmitter/receiver receiver which        generates and receives ultrasonic signals suitable for imaging        the blood of the brain,    -   b) at least one apparatus to dynamically couple any of the        ultrasonic transmitter/receivers to at least one opening in the        skull of the patient; and    -   c) a processor for imaging the blood vessels of the brain from        at least one signal received from at least one ultrasonic        transmitter/receiver.-   58. The system of any of inventions 55, 56, or 57, further    comprising acoustic coupling material positioned between the    ultrasonic transmitter/receiver and the skull.-   59. The system of any of inventions 55, 56, or 57, in which the    ultrasonic transducer/receiver is coupled to at least one man-made    opening in the skull.-   60. The system of any of inventions 55, 56, or 57, in which the    ultrasonic transducer/receiver is coupled to at least ocular opening    in the skull.-   61. The system of any of inventions 55, 56, or 57, in which the    ultrasonic transducer/receiver is coupled to at least one nasal    opening in the skull.-   62. The system of any of inventions 55, 56, or 57, in which the    ultrasonic transducer/receiver is coupled to at least one aural    opening in the skull.-   63. The system of any of inventions 55, 56, or 57, in which the    ultrasonic transducer/receiver is coupled to at least one acoustic    bone window in the skull.-   64. The system of any of inventions 55, 56, or 57, in which more    than one transducer/receiver is dynamically coupled to a like number    of openings, but only a single image is produced.-   65. An apparatus for diagnosing hemorrhagic stroke in a patient    having a skull containing brain tissue and blood vessels,    comprising:    -   a) at least one ultrasonic transmitter/receiver; and    -   b) a subassembly that dynamically couples at least one        ultrasonic transmitter/receiver to the skull of the patient.-   66. An apparatus for diagnosing ischemic stroke in a patient having    a skull containing brain tissue and blood vessels, comprising:    -   a) at least one ultrasonic transmitter/receiver; and    -   b) at least one subassembly that dynamically couples at least        one ultrasonic transmitter/receiver to the skull of the patient.-   67. An apparatus for diagnosing between hemorrhagic and ischemic    stroke in a patient having a skull containing brain tissue and blood    vessels, comprising:    -   a) at least one ultrasonic transmitter/receiver; and    -   b) at least one subassembly that dynamically couples at least        one ultrasonic transmitter/receiver to the skull of the patient.-   68. The apparatus of any of inventions 65, 66, or 67, in which the    subassembly stabilizes the transducer/receiver to the skull.-   69. The apparatus of any of inventions 65, 66, or 67, further    comprising acoustic coupling material between the ultrasonic    transmitter/receiver and the skull.-   70. The apparatus of any of inventions 65, 66, or 67, in which    acoustic coupling material may be inserted into or removed from a    location between the ultrasonic transmitter/receiver and the skull.-   71. The apparatus of any of inventions 65, 66, or 67, in which    acoustic coupling material is supported by a disposable member that    may be inserted into or removed from a location between the    ultrasonic transmitter/receiver and the skull.-   72. The apparatus of any of inventions 65, 66, or 67, in which    normal operation of the apparatus is prevented in the absence of an    acoustic coupling material.-   73. The apparatus of any of inventions 65, 66, or 67, in which    normal operation of the apparatus occurs only in the presence of a    sufficient amount of an acoustic coupling material.-   74. The apparatus any of inventions 65, 66, or 67, in which the    apparatus further comprises:    -   a) a subapparatus that determines a quantity of an acoustic        coupling material positioned between the ultrasonic        transmitter/receiver and the skull, and    -   b) a subapparatus that modifies normal operation of the        apparatus based on the determined quantity of acoustic coupling        material.-   75. The apparatus of any of inventions 65, 66, or 67, in which the    apparatus further comprises a subapparatus that inserts acoustic    coupling material between the ultrasonic transmitter/receiver and    the skull.-   76. The apparatus of any of inventions 65, 66, or 67, in which the    apparatus further comprises a subapparatus that receives acoustic    coupling material between the ultrasonic transmitter/receiver and    the skull.-   77. The apparatus of any of inventions 65, 66, or 67, in which the    apparatus inhibits diagnosis in the absence of sufficient acoustic    coupling material.-   78. The apparatus of any of inventions 65, 66, or 67, in which the    apparatus permits diagnosis only in the presence of sufficient    acoustic coupling material.-   79. The apparatus any of inventions 65, 66, or 67, in which the    apparatus further comprises:    -   a) a subapparatus that determines a quantity of acoustic        coupling material present and    -   b) a subapparatus that modifies diagnosis based on the quantity        of acoustic coupling material present.-   80. The apparatus of invention 65, in which the apparatus further    comprises:    -   a) a subapparatus that determines a quantity of acoustic        coupling material present and    -   b) a subapparatus that bases the determination of hemorrhagic        stroke, in part, on the quantity of acoustic coupling material        present.-   81. The apparatus of invention 66, in which the apparatus further    comprises:    -   a) a subapparatus that determines a quantity of acoustic        coupling material present and    -   b) a subapparatus that bases the determination of ischemic        stroke, in part, on the quantity of acoustic coupling material        present.-   82. The apparatus of invention 67, in which the apparatus further    comprises:    -   a) a subapparatus that determines a quantity of acoustic        coupling material present and    -   b) a subapparatus that bases the discrimination between        hemorrhagic stroke and ischemic stroke, in part, on the quantity        of acoustic coupling material present.-   83. A process, subprocess, apparatus, or system that detects or    measures or assesses the amount or quality of dynamic coupling    between a transducer/receiver and a skull, and then inhibits or    permits or modifies diagnosis of stroke accordingly.-   84. A process, subprocess, apparatus, or system that detects or    measures or assesses the amount or quality of dynamic coupling    between a transducer/receiver and a skull, and then inhibits or    permits or modifies diagnosis of stroke accordingly using closed    loop control of the amount or quality of dynamic coupling.-   85. Each of the embodiments of invention 84 in which the closed loop    control is performed using an algorithm selected from the group    consisting essentially of all possible combinations of proportional    control, integral control, and derivative control.-   86. Each of the embodiments of invention 84 in which the amount or    quality of dynamic coupling is adjusted by adjusting the extent of a    vacuum applied to the skull.-   87. Each of the embodiments of invention 84 in which the amount or    quality of dynamic coupling is adjusted by adjusting the amount or    location of an acoustic coupling material between the    transducer/receiver and the skull.-   88. Each of the embodiments of inventions 86 or 87 in which the    amount or quality of dynamic coupling is adjusted in a single    location.-   89. Each of the embodiments of inventions 86 or 87 in which the    amount or quality of dynamic coupling is adjusted in multiple    locations by respective amounts that may or may not be the same in    each location.-   90. Each of the embodiments of invention 84 in which the amount or    quality of dynamic coupling is adjusted by modifying an imaging    process.-   91. A process, subprocess, apparatus, or system for identifying type    of stroke in a patient having a skull containing brain tissue and    blood vessels, comprising:    -   a) at least one ultrasonic transmitter/receiver; and    -   b) at least one apparatus to dynamically couple at least one        ultrasonic transmitter/receiver to the skull of the patient;        in which the process, subprocess, apparatus, or system:    -   c) creates a non-Doppler ultrasonic image of a blood vessel        serving the brain;    -   d) creates a Doppler ultrasonic image of microparticulates        flowing in the blood vessel; and    -   e) identifies type of stroke based on flow rate of the        microparticulates.-   92. A process, subprocess, apparatus, or system for identifying type    of stroke in a patient having a skull containing brain tissue and    blood vessels, comprising.    -   a) at least one ultrasonic transmitter/receiver; and    -   b) at least one apparatus to dynamically couple at least one        ultrasonic transmitter/receiver to the skull of the patient;        in which the process, subprocess, apparatus, or system:    -   c) creates a harmonic ultrasonic image of the blood vessels        serving the brain,    -   d) creates a Doppler ultrasonic image of microparticulates        flowing in the blood vessels serving the brain, and    -   e) identifies type of stroke based on identification and        comparison of at least one zone of diffuse blood flow and at        least one zone of normal tissue.-   93. A process, subprocess, apparatus, or system for dynamically    coupling an ultrasonic transmitter/receiver to a skull of a patient    such that the process, subprocess, apparatus, or system creates an    ultrasonic image of brain tissue or blood vessels, comprising:    -   a) positioning, adjacent the skull, a platform which comprises        at least one suction port;    -   b) coupling the platform to the patient by the application of        suction to at least one suction port; and    -   c) coupling the ultrasonic transmitter/receiver to the platform.-   94. Each of embodiments of invention 93 in which the platform is    shaped in at least a portion of a circular arc.-   95. Each of embodiments of invention 93 in which the platform    comprises at least two portions, each of which is shaped in at least    a portion of a circular arc, the two portions being arranged    generally opposite each other.-   96. Each of embodiments of invention 93, further comprising    adjusting the amount and/or location of acoustic coupling material    between the ultrasonic transducer/receiver and the skull.-   97. Any of the previous embodiments of inventions 1-96, embodied in    a portable form suitable for mounting on the patient's head.-   98. Any of the previous embodiments of inventions 1-97, in which the    ultrasonic system is a portable system as disclosed (and especially    as claimed) in any of the patents cited above that are assigned to    Sonosite or ATL.-   99. Any of the previous embodiments of inventions 1-97, in which the    ultrasonic system uses techniques disclosed (and especially as    claimed) in any of the patents cited above that are assigned to    EchoCath, especially EchoFlow.-   100. Any of the previous embodiments of inventions 1-99, in which    the image processor includes an expert system.-   101. Any of the previous embodiments of inventions 1-100, in which    the image processor includes a neural network.

We claim:
 1. Using non-ultrasonic detection of symptoms of stroke todynamically couple an ultrasonic transducer/receiver to a skull, inwhich the non-ultrasonic detection comprises at least one of the groupconsisting of computed tomography scanning, magnetic resonance scanning,differential spectrophotometric methods, near-infrared detection oftissue characteristics, detection of a biological material, measurementof a biological material, detection of a chemical, measurement of achemical, detection of S100β, measurement of S100β, use of biologicalassay techniques, detection of change in blood pressure, detection ofchange in pressure within the eye, detection of change in blood flow inarteries serving organs other than the brain, or detection of change inblood flow in the arteries serving the eye.
 2. For a patient having askull containing brain tissue and blood vessels, a process fordiagnosing stroke in the patient, comprising: a) dynamically coupling atleast one ultrasonic transmitter/receiver to at least one man-madeopening in the skull of the patient; b) imaging a region within theskull of the patient; and c) at least one of: determining presence ofhemorrhagic stroke by identifying relatively diffuse blood flow withinthe skull of the patient; determining presence of ischemic stroke byidentifying at least one location of inadequate blood flow within theskull of the patient; and diagnosing between hemorrhagic and ischemicstroke by classifying a region within the skull of the patient in termsof adequacy of blood flow.
 3. The process of claim 2, in which theimaging comprises generating and receiving ultrasonic signals suitablefor processing into information about the region within the skull of thepatient.
 4. The process of claim 2, in which a region is classified interms of normal blood flow.
 5. The process of claim 2, in which a regionis classified in terms of inadequate blood flow.
 6. The process of claim2, in which a region is classified in terms of relatively diffuse bloodflow.
 7. The process of claim 2, in which locations of hemorrhagicstroke are determined by identifying relatively diffuse blood flowoutside the blood vessels of the brain.
 8. The process of claim 2 inwhich locations of ischemic stroke are determined by identifyingrelatively inadequate blood flow within the blood vessels of the brain.9. The process of claim 2 in which presence of ischemic stroke isdetermined by identifying at least one location where there is at leastpartial blockage of blood flow.
 10. The process of claim 2, furthercomprising applying a vacuum to the skull.
 11. The process of claim 2,further comprising applying an acoustic coupling material to the skull.12. A stroke diagnosis/treatment method comprising: mounting a unithaving two transmitter/receivers on the head of a subject with eachtransmitter/receiver acoustically coupled to an acoustic window of theskull, wherein each transmitter/receiver includes a plurality ofultrasonic transducing elements; activating at least some of thetransducing elements to direct ultrasonic signals into the brain;receiving echo signals from brain tissue and microbubbles in a bloodvessel of the brain with one of the transmitter receivers; processingthe echo signals to form two-dimensional or three-dimensional dynamicimages of the brain tissue and microbubbles in the blood vessel of thebrain; and diagnosing stroke from an image of the brain tissue and themicrobubbles.
 13. The method of claim 12, wherein diagnosing furthercomprises diagnosing whether a stroke has occurred and, if so, what typeof stroke has occurred.
 14. The method of claim 13, wherein diagnosingwhether a stroke has occurred further comprises identifying a bloodvessel which may be blocked.
 15. The method of claim 13, whereinidentifying a blood vessel which may be blocked further comprisesdetermining the type of stroke as ischemic.
 16. The method of claim 12,wherein diagnosing whether a stroke has occurred further comprisesidentifying a region of relatively diffuse blood flow.
 17. The method ofclaim 16, wherein identifying a region of relatively diffuse blood flowfurther comprises determining the type of stroke as hemorrhagic.
 18. Themethod of claim 12, further comprising: following the diagnosis of astroke, performing stroke therapy; and delivering additional ultrasonicenergy during the stroke therapy.
 19. The method of claim 18, whereindelivering additional ultrasonic energy during the stroke therapyfurther comprises delivering additional ultrasonic energy to the brainfrom which the image of microbubbles in a blood vessel was formed toimprove the effectiveness of therapy.
 20. The method of claim 19,wherein the image of microbubbles in a blood vessel further comprises aDoppler ultrasonic image of microbubbles in a blood vessel.
 21. A methodfor performing non-ultrasonic detection of symptoms of stroke, themethod comprising: dynamically coupling an ultrasonictransducer/receiver to a patient; performing ultrasound imaging with theultrasonic transducer/receiver, the ultrasound imaging comprisingimaging microbubbles in the patient; performing non-ultrasonic detectionof symptoms of stroke in which the non-ultrasonic detection comprises atleast one of the group consisting of computed tomography scanning,magnetic resonance scanning, differential spectrophotometric methods,near-infrared detection of tissue characteristics, detection of abiological material, measurement of a biological material, detection ofa chemical, measurement of a chemical, detection of S100β, measurementof S100β, use of biological assay techniques, detection of change inblood pressure, detection of change in pressure within the eye,detection of change in blood flow in arteries serving organs other thanthe brain, and detection of change in blood flow in the arteries servingthe eye; and determining a diagnosis of stroke based at least in-part onthe ultrasound imaging and a detection of symptoms of stroke whenperforming the non-ultrasonic detection of systems of stroke.